WHO: China’s State Food and Drug Administration (SFDA) as functional vaccine regulatory system

A WHO-led team, following “a comprehensive review by experts from six countries,” concluded that the national regulatory authority of China, the State Food and Drug Administration (SFDA) and affiliated institutions, “meet WHO-published indicators for a functional vaccine regulatory system.” WHO said it has established benchmarks that define international expectations for a functional vaccine regulatory system, and that it also conducts “regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way.” In addition to the general framework for the system, the following regulatory functions were evaluated: marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release by the national regulatory authority; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials. WHO said the review’s conclusion “is the culmination of 19 months of intensive effort by the SFDA to implement a roadmap — developed by national experts, with continuous advice from WHO — to strengthen capacity for regulation of vaccines.”

WHO noted that, with a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for WHO prequalification of specific products, and that it is expected that vaccines from China could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers “is expected to have a significant, beneficial impact on global supply of vaccines of assured quality.”